BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM HCV 3.0

    MDR report key: 1372652 · Received May 1, 2009

    Report

    Report Number
    1415939-2009-00849
    Event Type
    Malfunction
    Date Received
    May 1, 2009
    Date of Event
    September 13, 2008
    Report Date
    September 13, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LATE MDR IS A RETROSPECTIVE FILING. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US. INVESTIGATION RESULTS: ONE RETURN SAMPLE WAS RECEIVED FROM THE CUSTOMER SITE AND SUBJECTED TO CONTINUATIVE TESTING AT ABBOTT. THE INVESTIGATION TEAM HAS COMPLETED AN INVESTIGATION AND THE RESULTS ARE AS FOLLOWS: ONE AXSYM ABBOTT REAGENT KIT (LOT NUMBER 63296LF00) STORED AT ABBOTT WAS TESTED FOR ANALYTICAL AND CLINICAL SENSITIVITY. CALIBRATION AND CONTROLS WERE WITHIN THE SPECIFICATION RANGE AS PER PACKAGE INSERT. ALSO, SENSITIVITY PANELS FOR CORE, C100 AND 33C EPITOPES WERE WITHIN THE SPECIFICATION RANGE. IN ADDITION, TWO ANTI-HCV SEROCONVERSION PANELS WERE TESTED WITH ABOVE MENTIONED REAGENT KIT AND SHOWED THE EXPECTED NUMBER OF REACTIVE BLEEDS WITH S/CO VALUES COMPARABLE TO AN IN-HOUSE REFERENCE REAGENT LOT. BASED ON THIS INVESTIGATION, IT IS DETERMINED THAT AXSYM ABBOTT HCV REAGENT KIT, LIST NUMBER 1D30-20, IS PERFORMING ACCEPTABLY WITH RESPECT TO SENSITIVITY CLAIMS. REGARDING THE PATIENT SAMPLE RETURNED FROM THE CUSTOMER LABORATORY, REPRODUCIBILITY TESTING WITH AXSYM ABBOTT HCV REAGENT KIT (LIST NUMBER 1D30-20, LOT NUMBER 63296LF00) IN DUPLICATE RESULTED NON-REACTIVE WITH INDIVIDUAL VALUES OF 0.41 S/CO AND 0.33 S/CO. CHIRON RIBA HCV 3.0 SIA TESTING ALSO RESULTED NON-REACTIVE, CONFIRMING THE INITIAL RESULTS REPORTED TO ABBOTT AS WELL AS OUR REPRODUCIBILITY TESTING. THEREFORE, THE INVESTIGATION TEAM FOUND NO EVIDENCE FOR ANTI-HCV ANTIBODIES IN THE SAMPLE IN QUESTION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THIS LATE MDR IS A RETROSPECTIVE FILING FOR AN INTERNATIONAL PRODUCT WITH A SIMILAR US PRODUCT. THE ACCOUNT GENERATED A NONREACTIVE AXSYM HCV (0.39 S/CO) RESULT ON A SPECIMEN THAT TESTED QUICK CHASER METHOD POSITIVE. THE PHYSICIAN QUESTIONED THE AXSYM HCV NONREACTIVE RESULT AND STATED THE PATIENT SHOULD BE HCV ANTIBODY POSITIVE. THE SPECIMEN WAS REPEATED AGAIN WITH AN AXSYM HCV NONREACTIVE (0.29 S/CO) RESULT. THE ACCOUNT ALSO STATED THAT THE PATIENT WAS TESTED IN 2008 AND THERE WAS A DISCREPANCY AT THAT TIME AS WELL. NO FURTHER DETAILS WERE GIVEN REGARDING THE SAME DAY, DISCREPANCY. QUALITY CONTROL FOR THE AXSYM HCV TESTING WAS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM HCV 3.0 IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS MZO ABBOTT LABORATORIES 63296LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER